Mem Medical, Inc.: FDA clearances and approvals
Mem Medical, Inc. has 27 FDA 510(k) clearances (first 1979, latest 1979), across 11 product codes in 1 review panel. Median 510(k) review time: 12 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBO | Attachment, Intermittent Mandatory Ventilation (Imv) | 7 | 7 |
| CBP | Valve, Non-Rebreathing | 4 | 4 |
| BYP | Mouthpiece, Breathing | 3 | 3 |
| BYX | Tubing, Pressure And Accessories | 3 | 3 |
| CAF | Nebulizer (Direct Patient Interface) | 3 | 3 |
| BTC | Bag, Reservoir | 1 | 1 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BYG | Mask, Oxygen | 1 | 1 |
| BYH | Drain, Tee (Water Trap) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (25)
Most recent Mem Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K791913 | IMV MANIFOLD #M-506 | CBO | 1979-10-09 | 14 |
| K791912 | IMV FOR MONITORING #M-510 | CBO | 1979-10-09 | 14 |
| K791911 | FALL-SAFE IMV #M-511 | CBO | 1979-10-09 | 14 |
| K791910 | THREE LITER BAG #M-512 | BTC | 1979-10-09 | 14 |
| K791909 | IMV BUSHING #M-513 | CBO | 1979-10-09 | 14 |
| K791908 | RETARD VALVE 3-STACK #M-514 | CBP | 1979-10-09 | 14 |
| K791907 | RETARD VALVE 3-STACK #M-515 | CBP | 1979-10-09 | 14 |
| K791906 | IMV W/BAG #M-507 | CBO | 1979-10-09 | 14 |
| K791905 | IMV W/BAG & TUBING #M-508 | CBO | 1979-10-09 | 14 |
| K791904 | IMV W/BAG & HOSES #M-509 | CBO | 1979-10-09 | 14 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mem Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Mem Medical, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Mem Medical, Inc. have?
Mem Medical, Inc. has 27 FDA 510(k) clearances (first 1979, latest 1979), across 11 product codes in 1 review panel.
How long does FDA take to clear Mem Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mem Medical, Inc.'s cleared 510(k)s is 12 days.
What devices does Mem Medical, Inc. make?
Its most frequent FDA product codes are CBO (Attachment, Intermittent Mandatory Ventilation (Imv), 7); CBP (Valve, Non-Rebreathing, 4); BYP (Mouthpiece, Breathing, 3).
Has Mem Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mem Medical, Inc. Related entities may recall under other names.
Next steps
- See all 27 Mem Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBO, Mem Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.